On February 16, ASCP Washington Office staff testified before the Clinical
Laboratory Improvements Advisory Committee (CLIAC) on the issue of cytology
proficiency testing. (see related article below) Testimony by ASCP senior
manager for federal and state affairs, Matthew Schulze, raised concerns
about the looming requirement that all laboratories performing cytology
services will have to implement a cytology proficiency testing program in
2005 and urged revision of the cytology PT rule.

While acknowledging that the Centers for Medicare and Medicaid Services
(CMS) had a statutory obligation to implement a nationwide cytology
proficiency testing program, ASCP noted that members of the cytopathology
community are concerned with the recent CMS approval of the Midwest
Institute for Medical Education as the sole nationwide cytology proficiency
testing provider.

ASCP's testimony raised questions about the science behind the current
cytology regulation and whether it will enable an approved cytology
proficiency testing program to accurately and reliably assess the competency
of cytopathologists and cytotechnologists. The regulation, promulgated in
1992, does not reflect important scientific, medical and technological
advancements that have since occurred, such as the Bethesda system for
reporting Pap results and the 2001 Consensus Guidelines for the Management
of Women with Cervical Cytological Abnormalities. ASCP stated that it does
"not believe sufficient attention has been paid to address the integrity,
validity and scientific questions surrounding the federal government's
current approach" to testing competency for cytology services.

At the meeting ASCP urged the federal government to revise the cytology
proficiency testing rule, asking that "work on a modernized cytology
proficiency testing regulation begin immediately." In response to ASCP's
testimony and that of a former CLIAC member George Birdsong, MD, the
committee passed a unanimous motion urging the federal government to update
the cytology proficiency testing regulations as soon as possible.

CLIAC Discusses Cytology Proficiency Testing, Waived Testing

On February 16th and 17th, the Clinical Laboratory Improvements Advisory
Committee (CLIAC) met in Atlanta, GA. CLIAC discussed a number of issues
most notably cytology proficiency testing, on which ASCP testified, and a
proposed waived testing regulation.

Judy Yost of the Centers for Medicare and Medicaid Services (CMS) initiated
the discussion of cytology proficiency testing during her agency update. She
provided a brief overview of the historical and current implementation
issues and Cheryl Wiseman from CMS briefed CLIAC on the legal,
implementation, diagnostic categories, and data collection issues pertaining
to agency's approval of the Midwest Institute for Medical Education. Her
presentation provided a synopsis of the structure that will be used by MIME
to assess pathologist and cytotechnologist competency.

Following Ms. Wiseman's presentation, CLIAC briefly discussed cytology
proficiency testing. Several committee members expressed concerns about the
agency's implementation of a cytology proficiency testing requirement and
suggested revising the rule. Among the concerns mentioned were the scoring
system used to assess competency as well as the outdated "results
classification" scheme used to grade glass slides. Agency staff acknowledged
these concerns but noted that the regulations require the agency to
implement a cytology proficiency testing program if a nationwide provider
can earn agency approval. When MIME met the agency's requirements for
approval, the agency was legally obligated to require persons performing
cytology services to successfully complete the approved cytology proficiency
program. CMS staff noted that the agency will monitor implementation of the
cytology proficiency testing program and if it proves problematic, the
agency can take corrective action.

With regard to waived testing, the Food and Drug Administration's (FDA) Jean
Cooper reported that the FDA waiver guidance is expected to be released in
summer 2005. Members of CLIAC expressed disappointment that the guidance
document has not yet been released, noting that they view the guidance
document, on which a CLIAC subcommittee had provided recommendations, as
crucial to quality laboratory testing. The document provides guidance to
manufacturers on the steps necessary to gain waived status of testing
devices.

In addition, CLIAC member Jared Schwartz, MD, PhD presented the
recommendations of a CLAIC Subcommittee created to provide good laboratory
practices for waived testing. The recommendations cover considerations
before testing, test performance, and personnel training/continuing
education. CLIAC requested that CDC disseminate the document.

ASCP Content with NIH Final Rule on Open Access Publishing

The National Institutes of Health (NIH) recently announced its final rule
regarding the publication of studies based on research funded in part by NIH
grants. The rule represents a scaled back version of its initial plans to
require all NIH grantees to provide NIH with electronic copies of all
manuscripts within six months upon acceptance for publication by a
peer-reviewed journal. The scaled back rule is a victory for ASCP and other
scientific organizations that advocated that NIH revise its rule.

In the final rule, NIH now requests and strongly encourages that authors
specify posting of their final manuscripts for public accessibility as soon
as possible within 12 months of the publisher's official date of final
publication. NIH is also requesting funded investigators submit an
electronic version of their final manuscripts to the NIH National Library of
Medicine's (NLM) PubMed? Central (PMC) upon acceptance for publication by an
outside journal. The author's final manuscript is defined as the final
version accepted for journal publication, and includes all modifications
from the publishing peer review process. The rule goes into effect May 2,
2005.

ASCP is supportive of public access to research information but submitted
comments to NIH in strong opposition to the notice due to a number of
science, business and administrative related concerns. ASCP argued that rule
could have significant adverse effects on professional societies, such as
ASCP, that publish scientific journals like the American Journal of Clinical
Pathology (AJCP). The initial rule removed the only financial incentives
(e.g., paid subscriptions, advertising dollars, etc.) that exist for
nonprofit medical specialty societies to publish expert level research.
Without financial incentives, publishers would no longer be able to support
the backend work of peer review, which is the actuating of review comments
and findings. ASCP also expressed a number of administrative concerns
including the fact that the proposal was not developed through an open
process, but by invitation only.

President George W. Bush sent his 2006 fiscal year (FY) budget proposal to
Congress on February 7, 2005, and the implications for pathology and
laboratory medicine are cause for concern. The President's proposals to rein
in federal spending on federal discretionary and mandatory spending programs
will put significant pressure on lawmakers to eliminate or cut many
healthcare programs.

In recent years, the laboratory community has had success in maintaining or
limiting cuts in federal funding for programs important to the laboratory
community. Eliminating the proposed laboratory copayment provisions for
Medicare in 2003 and the annual ritual that restores funding for Title VII
allied health training programs are two examples. That said, congressional
lawmakers are increasingly calling for fiscal restraint and this may not
bode well for physician and laboratory reimbursements and laboratory
personnel training programs.

In his FY 2006 budget, President Bush requested $2.5 trillion in overall
federal spending. Not surprisingly, Bush's spending plans increase funding
for defense and foreign aid projects, while proposing serious reductions in
funding for a diverse array of other programs, such as health spending for
the poor and veterans. To achieve his promise to cut the deficit in half by
2009, his plan would hold non-defense spending flat over the next five
years.

Of interest to laboratory professionals, President Bush, as in years past,
has proposed deep cuts in the Title VII allied health programs. Under his
proposal, the allied health and other disciplines program would be
eliminated and funding for the scholarship for disadvantaged students
program would be reduced to $10 million in FY 2006. In total, the
President's budget would allocate only $11 million to the Title VII allied
health professions programs, cutting them by 96 percent. For the current
2005 FY, Title VII received a total of $299.6 million, with the allied
health and other disciplines program receiving $11.8 million and the
scholarships for disadvantaged students program receiving $47.1 million.

ASCP will be active this year in supporting programs that improve patient
health and provide training for essential laboratory personnel. Watch for
action alerts and visit the ASCP e-Advocacy Center
(http://capwiz.com/ascpath/home/) to assist with our advocacy efforts.

ASCP Campaign to "Thaw the Freeze" on Medicare Fee Schedule: Phase II

ASCP has launched Phase II of our "Thaw the Freeze" campaign this month.
ASCP initiated the original "Thaw the Freeze" campaign in 2004 to ask
lawmakers to restore inflationary updates to the Medicare clinical
laboratory fee schedule. The most recent version of the freeze was imposed
with passage of the Medicare Prescription Drug, Improvement, and
Modernization Act (MMA). It freezes annual updates to Medicare reimbursement
for laboratory services for the next five years. During Phase I of the
campaign, ASCP gathered over 1,500 signatures asking policymakers to restore
the annual updates to the fee schedule.

Phase II allows participants in the campaign to use their own voice to
describe how the freeze directly affects their work and their work
environment, and comment on issues of patient care and the practice of
pathology across the country. An alert was sent to all members who
participated in the first phase of the campaign via email. If you would like
to join our campaign, first use our e-Advocacy Center to sign the petition
by clicking the following link:
http://capwiz.com/ascpath/issues/alert/?alertid=5379011&type=CUBy signing the petition, you will receive an invitation to participate in
Phase II. We look forward to receiving your narratives.

Critical Access to Clinical Laboratory Services Introduced in Senate

Senators Ben Nelson (D-NE) and Susan Collins (R-ME) recently introduced the
Critical Access to Clinical Lab Services Act, S. 236, in the United States
Senate. The bill is intended to provide cost-based Medicare payments for
Critical Access Hospital (CAH) laboratory services regardless of where the
laboratory specimen is collected. This would be accomplished through changes
in the Social Security Act. These services include testing such as basic
blood tests, nutrition during pregnancy, new born testing and diagnostic
procedures.

In 1997, Congress created the CAH program. These hospitals are based in
rural and remote areas, and are often a community's only source of health
care services. The program authorized cost-based reimbursement for Medicare
inpatient and outpatient services provided by these hospitals, regardless of
where the services were provided. A recent clarification by the Centers for
Medicare and Medicaid Services (CMS) changed this policy, by discontinuing
cost-based reimbursements for laboratory services unless the patient is
physically present in the hospital when the laboratory specimen is
collected. S. 236 would correct this ruling by CMS.

The California Laboratory Field Services Office recently released its
long-awaited emergency regulations to license medical laboratory technicians
(MLTs) and recognize national certification. While the regulations went into
effect immediately, California has yet to approve any technologist- or
technician-level national certification examinations. Laboratory Field
Services staff has said it could take several years before the process of
approving these examinations is complete.

With MLT licensure requiring passage of an approved examination, the lack of
an acceptable examination for technicians means their licensure will have to
wait until the state has approved an examination for them to take.
Unfortunately for those interested in working in California as a medical
laboratory technician, temporary licensure, which temporarily licenses
individuals who have not yet passed an approved examination, is not an
option.

Moreover, it may take time to resolve some of the concerns that national
certification organizations have with the regulations. For example, the
regulation requires national certification organizations to give the state
several copies of their certifying examinations. It also requires them to
test individuals who do not meet the certification requirements specified by
each national certification organization.

Assuming these issues can be addressed and the state approves technologist-
and technician-level examinations, the state will be able to license medical
laboratory technicians as well as medical and other technologists who have
been nationally certified. National certification will definitely help the
state, which currently can offer its state exam only once a year. There is a
catch with regard to the state's plans for recognizing national
certification, however. Unfortunately the state is only willing to recognize
those certifications earned within four years of the approval of the
organization's examinations.

ASCP will provide an overview of the California MLT licensure requirements
in next Month's issue of e-Policy.

Florida Laboratory Industry Still Under Assault from State

While the State of Florida recently withdrew its competitive bidding plan
for Medicaid laboratory services, it appears posed to institute a 10 percent
reduction in reimbursements on these services.

The Florida Agency for Health Care Administration (AHCA) recently pulled a
revised competitive bidding proposal. The plan was released on December 13,
2004 and was immediately challenged by the laboratory industry. The proposal
was a revision of a previous AHCA competitive bidding scheme released on
March 2, 2004. ASCP opposed both proposals.

The American Clinical Laboratory Association (ACLA) filed a legal challenge
against AHCA's plan. Its challenge resulted in the suspension of the state's
plan, and likely triggered its withdrawal. No official reason for the
withdrawal was provided by the state.

ACLA's legal challenge argued the plan would adversely affect the quality
of, and access to, health care services, particularly for the poor. ACLA's
legal challenge also argued that some of the plan's provisions violated both
federal and state patient confidentiality laws.

The proposal would have required Florida's outpatient Medicaid laboratory
services to be handled by one clinical laboratory, rather than the 160
clinical laboratories currently serving more than 1.1 million Florida
Medicaid beneficiaries.

The withdrawal of AHCA's competitive bidding program is good news for
Florida's Medicaid beneficiaries, clinical laboratories and laboratory
personnel, since the plan would have required the state's entire outpatient
Medicaid laboratory testing to be performed by one laboratory.
Unfortunately, the state has announced its intent to implement a 10 percent
cut in spending on Medicaid outpatient laboratory services at the beginning
of April.

Questions have been raised among laboratory organization leaders whether the
state will be able to implement that cut, given the limited time available
to the state to implement a cut and that the statutory authority for the cut
appears to expire in July. Regardless, ASCP, ACLA and other laboratory
organizations are preparing for the Florida legislature's upcoming March
legislative session, and plan to oppose any possible cuts in laboratory
reimbursements.

The ASCP Commission on Public Policy (CPP) recently reviewed JCAHO's goals
on behalf of the Society. The CPP expressed unease over the applicability of
the draft standards to laboratory personnel. Specifically, ASCP is concerned
over issues of worker fatigue resulting not only from long hours, but also
from overwork in a specific period of time. Concerns over the amount of time
that laboratory personnel spend reviewing JCAHO patient safety and education
regulations were also expressed. ASCP believes that, because most laboratory
professionals are removed from direct patient contact, the focus of their
patient safety duties should be guaranteeing accurate and reproducible
results-- not addressing patient medical literacy or distributing
administrative records.

ASCP Thanks Licensure Survey Participants

ASCP would like to thank its members who participated in the Society's
recent member survey on the licensure of laboratory personnel. More than
10,000 ASCP members participated in the survey, including more than 500
pathologists. The survey collected an extensive amount of data on ASCP
member views on licensure and the Society is currently in the process of
analyzing the data. ASCP will publish the results of the survey this summer.

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Contributors to this page: JSullinger@ameripath.com
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